1. Field of the Invention
The present invention relates to antibodies that may be used, for example, in the diagnosis, treatment and prevention of hepatocellular carcinoma (HCC), liver cancer and related conditions.
2. Background Information
PIVKA-II is a Prothrombin Induced Vitamin K Antagonist (PIVKA) specific to Factor II. The GLA domain of Prothromin II or Factor II undergoes a post-synthetic modification in the presence of Vitamin K wherein 10 glutamic acid amino acids in the GLA-domain are carboxylated to g-carboxy glutamic acid. The carboxylation process is abherent in the diseased state. Thus, PIVKAII is known to be elevated in the case of HCC patients (Liebman et. al., The New England Journal of Medicine (1984), 310 (22), pages 1427-1431; Fujiyama et. al., Hepato-gastroenterology (1986), 33, pages 201-205; Marreo et. al., Hepatology (2003), 37, pages 1114-1121).
At present, there are inefficient methods by which to detect HCC or liver cancer by use of biomarkers (Koteish et. al., J. Vasc. Interv. Radiol. (2002), 13, pages 185-190; Yuen et. al., Best Practice & Research Clinical Gastroenterology (2005), 19, pages 91-99; see also Herai et al., Japanese Journal of Clinical Laboratory Automation (2007), 32(2), pages 205-210; Durazo et al., Journal of Gastroenterology and Hepatology (2008), 23, pages 1541-1548; Yamaguchi et al., Clin. Chem. Lab. Med. (2008), 46(3), pages 411-416). Further, there are few monoclonal antibodies in existence that can be used in immunoassays to effectively detect such conditions or to treat such conditions (Naraki et. al., Biochemica at Biophysica Acta (2002), 1586, page 287-298). Thus, there is a tremendous need in oncology for the development of antibodies that can be used efficaciously for both purposes.
All patents and publications referred to herein are hereby incorporated in their entirety by reference.